Establishing a Standard for Peri-operative Implantable Cardioverter Defibrillator (ICD) Patient Education

Not Applicable

Completed

• Conditions: Arrhythmia
• Interventions: Behavioral: Intervention

• Registration Number: NCT00845234
• Lead Sponsor: East Carolina University

Brief Summary

An implantable cardioverter defibrillator (ICD) administers a shock to terminate potentially life-threatening cardiac arrhythmias. The device saves lives, but presents psychological challenges for patients. At present, there is a paucity of brief interventions for ICD patients designed for administration in a clinic setting that considers issues of cost, time, and available resources. The present study examined the impact of a brief cognitive behavioral (CBT) educational intervention on primary endpoints of patient acceptance and quality of life and secondary endpoints of depression and anxiety. It was hypothesized that the intervention would result in significant improvements primary and secondary endpoints for participants in the intervention group.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-18
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-25
• Last Update Posted: 2013-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• 18+ years old
• literate
• newly implanted with an implantable cardioverter defibrillator (ICD)

Exclusion Criteria

• documented neurological sequelae associated with CVA or dementia
• documented cognitive impairment
• reported illiteracy
• previously implanted ICD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Intervention	Intervention group- Patients will receive the brief educational CBT intervention + video and Q\&A session

Primary Outcome Measures

Name	Time	Method
Score on measure assessing construct of quality of life	Up to 8 months after enrollment	Quality of life will be obtained via participants scores from the Medical Outcomes Survey Short Form-12 (SF-12) measure of quality of life.

Secondary Outcome Measures

Name	Time	Method
Score on measure assessing depression	Up to 8 months after enrollment	Depression will be assessed via participant's self-reported scores on the depression subscale of the Hospital Anxiety and Depression Scale (HADS).
score on measure assessing construct of patient acceptance of device	up to 8 months after enrollment	The Florida Patient Acceptance Scale measures patient's self-reported acceptance of the implantable cardioverter defibrillator.
score on measure assessing anxiety	Up to 8 months after enrollment	The Hospital Anxiety and Depression Scale is comprised of two subscales- anxiety and depression. It is a self-report measure that generates a score on the patient's current level of anxiety.

Trial Locations

Locations (2)

East Carolina Heart Institute; 🇺🇸 Greenville, North Carolina, United States

Aurora Denver Cardiology Associates; 🇺🇸 Lone Tree, Colorado, United States